BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PORTA MAXIMUM, MODEL# 2066

    FDA 510(k)
    FDA Class 2 ·Dental

    BODYSTAT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CORAIL AMT COLLAR SIZE 14

    FDA Adverse Event
    Injury ·3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code KWA·April 23, 2013

    CS300

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·March 31, 2011

    MARQUIS DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·July 10, 2008

    145-DEG PE 42MM CONST HUM LINER +2.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·April 8, 2025

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015